Factor Consumption for Prophylaxis and Treatment of Bleeding: Recombinant Factor Ix Fc Fusion Protein Compared With Conventional Recombinant Factor Ix
نویسندگان
چکیده
منابع مشابه
Population Pharmacokinetic Modelling of Recombinant Factor IX Fc Fusion Protein (rFIXFc) in Patients with Haemophilia B
BACKGROUND AND OBJECTIVES Recombinant factor IX Fc fusion protein (rFIXFc) is a clotting factor developed using monomeric Fc fusion technology to prolong the circulating half-life of factor IX. The objective of this analysis was to elucidate the pharmacokinetic characteristics of rFIXFc in patients with haemophilia B and identify covariates that affect rFIXFc disposition. METHODS Population p...
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Background: Human coagulation factor IX (hFIX) is a glycoprotein with two N-glycosylation sites at the activation peptide. Since the activation peptide is removed in mature hFIX, the exact role of N-glycosylation is unclear. To investigate the role of N-glycosylation in the secretion and activity of hFIX, we inhibited N-glycosylation by tunicamycin in the stable Human Embryonic Kidney (HEK)- c...
متن کاملValidation of the manufacturing process used to produce long-acting recombinant factor IX Fc fusion protein
Recombinant factor IX Fc (rFIXFc) fusion protein is the first of a new class of bioengineered long-acting factors approved for the treatment and prevention of bleeding episodes in haemophilia B. The aim of this work was to describe the manufacturing process for rFIXFc, to assess product quality and to evaluate the capacity of the process to remove impurities and viruses. This manufacturing proc...
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Background: Pilot and large-scale production of recombinant proteins requires the presence of stable clones capable of producing large quantities of recombinant proteins. Not only the process of selecting stable clones is time consuming, but also the continuous culturing of clones in large-scale production may cause loss of incoming plasmid and recombinant genes. Thus, considering the advanceme...
متن کاملPhysical activity in individuals with haemophilia and experience with recombinant factor VIII Fc fusion protein and recombinant factor IX Fc fusion protein for the treatment of active patients: a literature review and case reports
The World Federation of Hemophilia and the National Hemophilia Foundation encourage people with haemophilia (PWH) to participate in routine physical activity. The benefits of physical activity for PWH include improvements in joint, bone, and muscle health. Accordingly, a number of studies suggest that levels of physical activity among PWH are similar to those of their healthy peers, especially ...
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ژورنال
عنوان ژورنال: Value in Health
سال: 2015
ISSN: 1098-3015
DOI: 10.1016/j.jval.2015.09.2396